The purpose of this study is to determine the subjective response of iron substitution (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin \< 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation.
* Actually, there's no recommendation to check ferritin level in blood donors, even if several studies pointed out the high prevalence of iron deficiency after a blood donation. Furthermore, some clinical trials showed that non-anaemic women with unexplained fatigue may benefit from iron supplementation. * The purpose of this study is to determine the subjective response of iron substitution (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin \< 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation. * We will measure blood count, ferritin level and C-reactive protein at the time of the blood donation and then after a week, a month and 3 months. A week after the blood donation, donors with a ferritin level \<30 ng/ml and hemoglobin \> 120g/l (non anaemic) will be included in the study and randomised. A one-month iron treatment vs placebo will be introduced. To assess the subjective response on fatigue, the donors will fill in different questionnaires at the time of the blood donation and then after a week, a month and 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
154
Volunteers will receive 80 mg/day oral ferrous sulphate (Tardyferon®) for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue (" Fatigue Severity Scale"). We will also check depression and anxiety symptoms (" Prime MD ") and health survey (" SF-12 "). An evaluation of the menstruation (" Pictorial Bleeding Assessment Chart " of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes.
Volunteers will receive 1 pill/day oral placebo for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue (" Fatigue Severity Scale"). We will also check depression and anxiety symptoms (" Prime MD ") and health survey (" SF-12 "). An evaluation of the menstruation (" Pictorial Bleeding Assessment Chart " of Jansen) will be performed at day 0 to detect a possible hypermenorrhea (appendix 1-4). A physical test will be performed (Chester Step Test) to assess the VO2 max. Every side effect will be written on follow-up notes.
Department of Ambulatory Care and Community Medicine, University Hospitals of Lausanne
Lausanne, Bugnon 44, Switzerland
Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.
The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from "no fatigue=0" to "very severe fatigue=10".
Time frame: baseline and 4 weeks
Hemoglobin Variation Before and After Treatment vs Placebo
The level of hemoglobin measured 4 weeks after randomization
Time frame: baseline and 4 weeks
Ferritin Change Before and After 4 Weeks of Treatment/Placebo
Level of ferritin measured 4 weeks after randomization
Time frame: baseline and 4 weeks
Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test
Subjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate.
Time frame: baseline and 4 weeks
Response of Iron Supplementation on Mental Disorder
Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score \>15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or \<15) after placebo or treatment.
Time frame: baseline and 4 weeks
Adherence to Treatment.
Adherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland)
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Time frame: 4 weeks